Sechrist Monoplace Hyperbaric Oxygen Chamber
FDA 510(k) K140559 · Sechrist Industries, Inc.
510(k) numberK140559
Submission
- Device name
- Sechrist Monoplace Hyperbaric Oxygen Chamber
- Applicant
- Sechrist Industries, Inc.
Anaheim, CA, US - Received
- March 5, 2014
- Decision date
- May 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBF – Chamber, Hyperbaric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5470
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K171899 | Revitalair 430FCBF · Traditional | Oxavita Srl | 11/22/2019SE |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special | Oxyheal Medical Systems, Inc. | 03/22/2017SE |
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| K102831 | Rsi 4200CBF · Abbreviated | Reimers Systems, Inc. | 08/19/2011SE |
| K092991 | O.S.C.A.R. (Operating System for Control and Record Keeping)CBF · Traditional | Environmental Tectonics Corp. | 08/13/2010SE |
| K101262 | Flexi-LiteCBF · Traditional | Pressure-Tech, Inc. | 06/10/2010SE |
| K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 04/26/2010SE |
| K082455 | Rectangular Multiplace Hyperbaric ChamberCBF · Traditional | Gulf Coast Hyperbarics, Inc. | 05/22/2009SE |
More from Gulf Coast Hyperbarics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | 04/26/2010SE |
| K052713 | Model 3300E/ER Monoplace Hyperbaric Oxygen ChamberCBF · Special | 10/28/2005SE |
| K023745 | Sechrist Air/Oxygen Mixer, Model 3500 Cp-GDTX · Traditional | 01/17/2003SE |
| K993167 | Millennium Infant VentilatorCBK · Special | 11/10/1999ST |
| K992503 | Sechrist Air-Oxygen Mixer, 3500/3500HL SeriesBZR · Special | 08/10/1999SE |
| K950386 | Model 3200P/3200PR Hyperbaric ChamberCBF · Traditional | 06/13/1995SE |
| K934164 | Model 2500E/2500ER Hyperbaric ChamberCBF · Traditional | 06/13/1995SE |
| K930713 | The Infant Flow SystemCAI · Traditional | 09/16/1993SE |
| K914607 | Sehrist Volume Ventilator, Model 2200BCBK · Traditional | 11/02/1992SE |
| K896269 | Sechrist Volume Ventilator Model 2200BCBK · Traditional | 05/18/1990SE |
Questions and answers
When was Sechrist Monoplace Hyperbaric Oxygen Chamber cleared by the FDA?
Sechrist Monoplace Hyperbaric Oxygen Chamber (K140559) received a 510(k) decision of Substantially Equivalent on May 30, 2014, 86 days after the submission was received.
What is the product code of K140559?
The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.